Cleared Special

K112559 - MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM

K112559 is an FDA 510(k) clearance for MEDAPPS 2.0 REMOTE PATIENT MONITORING S..., manufactured by Medapps, Inc.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Special 510(k) pathway after a 91-day FDA review.

K112559 · Medapps, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
91d
Days
Class 2
Risk

K112559 is an FDA 510(k) clearance for the MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Medapps, Inc. (Scottsdale, US). The FDA issued a Cleared decision on December 2, 2011 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K112559

510(k) Number K112559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2011
Decision Date December 02, 2011
Days to Decision 91 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

DRG Device Classification - Class 2, Special Controls

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 185
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K112559 · MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM
Download PDF FDA Summary Medapps, Inc.